In addition, our office will work with researchers for study-specific questions and any needed amendments or adjustments.
Human Subjects Research Announcement - COVID 19 (PDF)
We anticipate an increase in email and call volume. Please follow the instructions below to help us address all questions efficiently and not overload individual inboxes.
Priority 1: Any research related to COVID-19 and SARS-CoV-2
Priority 2: Amendments to research directly related to COVID-19 response in order to enhance participant safety
Priority 3: Reports of New Information (RNI) directly related to COVID-19
Priority 4: Continuing Reviews (CR) of studies based on upcoming expiration dates
Priority 5: All other submissions
To assist us in identifying priority submissions:
No. This is not a research activity and does not need IRB review.
Investigators are encouraged to modify their studies to replace in-person study visits with “remote” options for questionnaires, surveys, check-ins, screening and consenting. These changes still require IRB review and approval prior to implementation, unless they are necessary to eliminate immediate hazards to participants (see previous FAQ).
To modify your study to allow for remote visits, submit an amendment in eCompliance.
Investigators are encouraged to modify their studies to replace written informed permission/assent/consent with verbal permission/assent/consent if their study meets one of the regulatory criteria for a waiver of documentation [45 CFR 46.117(c)(1)] below.
To modify your study to allow for verbal permission/assent/consent, submit an amendment in eCompliance.
If temporarily halting research activities will have NO effect on the safety or welfare of participants you do not need to report this to the IRB.
If temporarily halting research activities could result in increased risk of harm or affect the welfare of subjects, you must submit an event report for IRB review and approval prior to halting research activities.
The primary concern for researchers should always be participant safety and developing contingency plans is encouraged.
There are clinical studies that include safety monitoring in the form of laboratory tests, examinations or surveys/interviews. Clinical investigators need to work closely with their research team and study sponsor (if applicable) to determine if modifications to safety monitoring are appropriate. Any modifications should be submitted as an amendment to the UMKC IRB, and we will work to efficiently review and process approvals. If there are immediate modifications required to eliminate possible hazards to subjects and there is not appropriate time to receive IRB approval, the UMKC IRB should be notified within five days using the event report in eCompliance. If the UMKC IRB is not the IRB of record and you are relying on another IRB, you will need to contact the reviewing IRB.
Screening for novel coronavirus may be a precaution taken by research units as part of public health surveillance. This type of screening does not need to be reported to or approved by the UMKC IRB and should follow protocols and procedures recommended by the facility where your research is being conducted. In addition, risks related to research participants do not need to be amended to address COVID-19 as these are not related to study procedures but general population health.
Study modifications to allow for remote interaction with subjects are allowable but require IRB approval through the amendment process in advance to ensure participant safety is not compromised. If there are immediate modifications required to eliminate possible hazards to subjects and there is not appropriate time to receive IRB approval, the UMKC IRB should be notified within five days using the event report in eCompliance.
You do not need to modify your protocol to allow for remote interaction or adjust your study schedule if your study has been determined Exempt or if the UMKC IRB-approved protocol does not stipulate how the visit/interaction would occur. In addition, some minimal risk studies may qualify for a waiver of documentation (signed) consent. If you wish to modify your minimal risk study to include this waiver of documentation, please submit an amendment through eCompliance (primarily for Expedited studies). An amendment is not required for Exempt studies.
If investigators decide to voluntarily suspend participant enrollment or participation for a significant amount of time (more than a month), this should be reported to the UMKC IRB with an amendment to temporarily close a study. Information will need to be provided to ensure participant safety is not adversely impacted by any participation suspension. If the UMKC IRB is not the IRB of record and you are relying on another IRB, you will need to contact the reviewing IRB.
Processes related to Emergency Use or Compassionate Use of a test article (drug, device or biologic) remain the same with respect to UMKC IRB approval. Our guidance (PDF) provides information on what is required and how to submit information to the UMKC IRB through eCompliance.
If investigators have the need to work remotely with research data as a result of UMKC-approved COVID-19 adjustments, steps should be taken to ensure all research-related data will remain secure. Investigators should work directly with their IT professionals to ensure they are working on UMKC encrypted devices and, if working remotely with files, are using approved solutions such as VPN client and remote desktop using VPN client and, if communicating via email, are only using their university email account and minimally necessary information.
If your study is a sponsored study, please communicate with the sponsor to determine if there are any expected changes to data reporting as a result of participants being under self-quarantine or if they contract the novel coronavirus, or to record any study modifications discussed above. If your study is not sponsored, please work with your research team (and reach out to the UMKC IRB if necessary) to determine how your data may potentially be impacted and what additional information and data points you need to capture.